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Provention Bio, Inc. (Nasdaq: PRVB) announced an investor event on May 19, 2022, focused on the anticipated commercial launch of teplizumab, an anti-CD3 monoclonal antibody under FDA review for delaying clinical type 1 diabetes in at-risk individuals. The event will run from 1:00 p.m. to 2:30 p.m. ET and will feature presentations from the commercial leadership team and a guest speaker, Dr. Kimber Simmons. The FDA's user fee goal date is August 17, 2022, marking a critical milestone for the drug's approval.
Provention Bio (Nasdaq: PRVB) announced the FDA's acceptance of their teplizumab Biologics License Application (BLA) resubmission, with a user fee goal date set for August 17, 2022. This therapy aims to delay clinical type 1 diabetes in at-risk individuals. The company's first-quarter 2022 results reveal a net loss of $22 million, a decrease from $32.4 million in Q1 2021, primarily due to a $7.1 million tax benefit and a reduction in research costs. Provention had $113.4 million in cash, sufficient to fund operations into Q1 2023.
On May 3, 2022, Provention Bio, Inc. (Nasdaq: PRVB) announced the grant of stock options to four new employees, totaling 110,000 shares. The options, exercisable at a price of $4.76, will vest over four years, contingent on the employees' continued service. This action was taken without stockholder approval, aligning with Nasdaq Listing Rule 5635(c)(4) and approved by the Company's compensation committee. Provention Bio is focused on developing therapies for immune-mediated diseases, including its lead candidate teplizumab for delaying Type 1 diabetes progression.
Provention Bio, Inc. (Nasdaq: PRVB) will announce its first quarter 2022 financial results on May 5, 2022, before U.S. market opening. A conference call will follow at 8:00 am E.T. to discuss results and company updates. Provention Bio focuses on developing therapies for immune-mediated diseases, including type 1 diabetes and lupus. Investors can access the call at 1-888-347-7861 (domestic) or 1-412-902-4247 (international), or via an audio webcast on the company's website. An archived version will be available shortly after the call.
Provention Bio, Inc. (Nasdaq: PRVB) announced the grant of stock options for 195,000 shares to two new employees, effective April 4, 2022. The options, approved by the compensation committee, were granted without stockholder approval as inducements for employment. Each option has a 10-year term with an exercise price of $7.30, the closing price on April 1, 2022. Vesting occurs with 25% after one year and 75% in monthly installments over four years, contingent on continued employment. Provention focuses on developing therapies for immune-mediated diseases, including its lead drug candidate teplizumab.
Provention Bio (Nasdaq: PRVB) announced positive final results from the PROVENT study of its investigational vaccine PRV-101, targeting coxsackievirus B (CVB) linked to type 1 diabetes (T1D) and celiac disease. The vaccine was well tolerated, with no serious adverse events, and showed durable viral neutralizing antibody responses in healthy volunteers. Six months after dosing, high antibody titers were maintained in 100% of high-dose subjects for most serotypes. This first-in-human trial paves the way for potential partnerships to advance the vaccine's development.
Provention Bio, Inc. (Nasdaq: PRVB) announced on March 4, 2022, the granting of stock options to two new employees for a total of 55,000 shares of common stock. This grant was made without stockholder approval as part of an inducement, following Nasdaq Listing Rule 5635(c)(4). The options have a 10-year term with an exercise price set at $6.26, the closing price on March 1, 2022. Vesting occurs with 25% after one year and the remainder in equal monthly installments over four years, contingent on continued employment.
Provention Bio (Nasdaq: PRVB) announced its participation in two virtual investor conferences in March 2022. CEO Ashleigh Palmer will present at the Cowen 42nd Annual Health Care Conference on March 8, 2022, at 9:50 am EST, with a live webcast accessible via the company's website. Additionally, Provention Bio will engage in a fireside chat at Oppenheimer & Co.'s 32nd Annual Healthcare Conference on March 16, 2022, at 2:00 pm EST, also available via webcast. Both presentations will be archived on the website for 30 days.
Provention Bio, Inc. (Nasdaq: PRVB) reported Q4 and full-year 2021 financial results, highlighting a net loss of $25.8 million for Q4 and $114.4 million for the year. The company emphasized its resubmission of the teplizumab BLA to the FDA to delay clinical type 1 diabetes in at-risk individuals. Key developments included successful enrollment in the Phase 3 PROTECT trial and the initiation of the PREVAIL-2 trial for PRV-3279. Provention's cash position at year-end was $127.1 million, sufficient for operations for the next 12 months, although additional capital will be needed if teplizumab is approved.
Provention Bio, Inc. (Nasdaq: PRVB) has resubmitted a Biologics License Application (BLA) for teplizumab, aimed at delaying clinical type 1 diabetes (T1D) in at-risk individuals. This action addresses concerns raised by the FDA in a complete response letter (CRL) from July 2021 regarding pharmacokinetic (PK) comparability, manufacturing, and product quality. The resubmission follows a Type B meeting with the FDA, establishing a pathway for PK modeling to adjust the dosing regimen. The FDA has 30 days to review the BLA and determine its completeness.
